Automatic selection of lead configuration for a neural stimulation lead

ABSTRACT

A neurostimulation system includes a neural stimulation lead having a proximal portion and a distal portion and including a plurality of electrodes along the distal portion. The plurality of electrodes are configured for positioning proximate a portion of the autonomic nervous system. A neural stimulation circuit, coupled to the plurality of electrodes, delivers neural stimulation pulses to the plurality of electrodes. A processor and controller is configured to control the neural stimulation circuit to deliver first neural stimulation pulses to each of a plurality of electrode configurations. Each electrode configuration includes one or more of the plurality of electrodes. The processor and controller is further configured to receive information related to motor fiber activity that is induced in response to delivery of the first neural stimulation pulses to each of the plurality of electrode configurations and to identify the electrode configurations that induce the motor fiber activity.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.13/893,080, filed May 13, 2013, now issued as U.S. Pat. No. 9,050,472,which is a continuation of U.S. patent application Ser. No. 13/220,423,filed Aug. 29, 2011, now issued as U.S. Pat. No. 8,452,406, which claimspriority to Provisional Application No. 61/383,192, filed Sep. 15, 2010,each of which are herein incorporated by reference in their entirety.

TECHNICAL FIELD

The present invention relates generally to implantable medical devices.More specifically, the present invention relates to automatic selectionof lead electrode configurations for medical device leads.

BACKGROUND

A significant amount of research has been directed both to the directand indirect stimulation and sensing of the left and right vagus nerves,the phrenic nerve, the sacral nerve, the cavernous nerve, and portionsof the anatomy with baroreceptors (e.g., the carotid artery) to treat awide variety of medical, psychiatric, and neurological disorders orconditions. For example, stimulation of the vagus nerve has beenproposed as a method for treating various heart conditions, includingheart failure. The nerves stimulated and/or sensed may be sympathetic orparasympathetic in character.

In a nerve stimulation and sensing system, one or more electrodes areformed on a lead that are electrically connected to an implantedelectronic package, such as a pulse generator. Electrical energy isdelivered to the electrodes by conductors that extend from the pulsegenerator at a proximal end of the lead to the electrodes at a distalend of the lead. For direct stimulation of a nerve, the electrodes maybe configured to be secured directly to, wrapped around, or positionednext to the nerve.

SUMMARY

Discussed herein are systems and methods for automatically selectingelectrode configurations for a neural stimulation lead by prioritizingthe electrode configurations with the most neural capture based on thedegree of physiological activity and therapeutic effect induced byneural stimulation signals.

In Example 1, a neurostimulation system includes a neural stimulationlead, a neural stimulation circuit, and a processor and controller. Theneural stimulation lead has a proximal portion and a distal portion andincludes a plurality of electrodes along the distal portion. Theplurality of electrodes are configured for positioning proximate aportion of the autonomic nervous system. The neural stimulation circuit,coupled to the plurality of electrodes, delivers neural stimulationpulses to the plurality of electrodes. The processor and controller isconfigured to control the neural stimulation circuit to deliver firstneural stimulation pulses to each of a plurality of electrodeconfigurations. Each electrode configuration includes one or more of theplurality of electrodes. The processor and controller is furtherconfigured to receive information related to motor fiber activity thatis induced in response to delivery of the first neural stimulationpulses to each of the plurality of electrode configurations and toidentify the electrode configurations that induce the motor fiberactivity.

In Example 2, the neurostimulation system according to Example 1,wherein the processor and controller is configured to control the neuralstimulation circuit to deliver the first neural stimulation pulses atmore than one energy level to each of the plurality of electrodeconfigurations.

In Example 3, the neurostimulation system according to either Example 1or 2, wherein the processor and controller is further configured toprioritize the plurality of electrode configurations based on a firstcapture threshold for the motor fiber activity.

In Example 4, the neurostimulation system according to Example 3,wherein the processor and controller further controls the neuralstimulation circuit to deliver second neural stimulation pulses to oneor more electrode configurations with a lowest first capture thresholdfor motor fiber activity and to receive information related to one ormore physiological responses that are induced in response to delivery ofthe second neural stimulation pulses to each of the plurality ofelectrode configurations.

In Example 5, the neurostimulation system according to any of Examples1-4, and further comprising one or more physiological activity sensorsconfigured to sense a signal indicative of the one or more physiologicalresponses and generate the information related to the one or morephysiological responses.

In Example 6, the neurostimulation system according to Example 4,wherein the one or more physiological responses include intendedphysiological activity and intolerable physiological activity, andwherein the processor and controller is further configured to eliminatethe electrode configurations that induce intolerable physiologicalactivity and to prioritize the one or more electrode configurations thatinduce intended physiological activity based on a second capturethreshold for the intended physiological activity.

In Example 7, the neurostimulation system according to any of Examples1-6, wherein the processor and controller is programmable to delivertherapy to at least one of the one or more electrode configurations thatinduce intended physiological activity at a lowest second capturethreshold.

In Example 8, the neurostimulation system according to any of Examples1-7, and further comprising an activity sensor configured to sense asignal indicative of motor fiber activity and generate the informationrelated to the motor fiber activity.

In Example 9, a method includes coupling a plurality of electrodes to aneural stimulation circuit that delivers neural stimulation pulses tothe plurality of electrodes, the plurality of electrodes positionedproximate a portion of the autonomic nervous system. The method alsoincludes controlling the neural stimulation circuit to deliver firstneural stimulation pulses to each of a plurality of electrodeconfigurations. Each electrode configuration comprises one or more ofthe plurality of electrodes. The method further includes receivinginformation related to motor fiber activity that is induced in responseto delivery of the first neural stimulation pulses to each of theplurality of electrode configurations and identifying the electrodeconfigurations that induce the motor fiber activity.

In Example 10, the method according to Example 9, wherein thecontrolling step comprises controlling the neural stimulation circuit todeliver the first neural stimulation pulses at more than one energylevel to each of the plurality of electrode configurations.

In Example 11, the method according to either Example 9 or 10, furthercomprising prioritizing the plurality of electrode configurations basedon a first capture threshold for the motor fiber activity.

In Example 12, the method according to Example 11, and furthercomprising controlling the neural stimulation circuit to deliver secondneural stimulation pulses to one or more electrode configurations with alowest first capture threshold for motor fiber activity; and receivinginformation related to one or more physiological responses that areinduced in response to delivery of the second neural stimulation pulsesto each of the plurality of electrode configurations.

In Example 13, the method according to Example 12, wherein the one ormore physiological responses include intended physiological activity andintolerable physiological activity, and wherein the method furthercomprises eliminating the electrode configurations that induceintolerable physiological activity and prioritizing the one or moreelectrode configurations that induce intended physiological activitybased on a second capture threshold for the intended physiologicalactivity.

In Example 14, the method according to any of Examples 9-13, and furthercomprising delivering therapy to at least one of the one or moreelectrode configurations that induce intended physiological activity ata lowest second capture threshold.

In Example 15, a method includes positioning a plurality of electrodesproximate a portion of the autonomic nervous system, the plurality ofelectrodes disposed along a distal portion of a neural stimulation lead.The neural stimulation lead is coupled to an external device configuredto deliver first neural stimulation pulses to the plurality ofelectrodes. The external device is then controlled to deliver firstneural stimulation pulses at more than one energy level to each of aplurality of electrode configurations. Each electrode configurationincludes one or more of the plurality of electrodes. Information isprovided to the external device related to motor fiber activity that isinduced in response to delivery of the first neural stimulation pulsesto each of the plurality of electrode configurations. An output isgenerated on the external device that prioritizes the plurality ofelectrode configurations based on a first capture threshold for themotor fiber activity.

In Example 16, the method according to Example 15, and furthercomprising coupling the neural stimulation lead to an implantablemedical device (IMD).

In Example 17, the method according to Example 16, wherein, after theIMD has been implanted for a period of time, the method furthercomprises controlling the IMD to deliver the first neural stimulationpulses at more than one energy level to each of the plurality ofelectrode configurations. Information is provided from the IMD to theexternal device related to motor fiber activity that is induced inresponse to delivery of the first neural stimulation pulses by the IMDto each of the plurality of electrode configurations. An output isgenerated on the external device that prioritizes the plurality ofelectrode configurations based on the first capture threshold for themotor fiber activity.

In Example 18, the method according to Example 17, and furthercomprising programming the IMD with the external device to deliversecond neural stimulation pulses to one or more of the electrodeconfigurations with a lowest first capture threshold for motor fiberactivity. Information is received by the external device related to oneor more physiological responses that are induced in response to deliveryof the second neural stimulation pulses to each of the plurality ofelectrode configurations.

In Example 19, the method according to Example 18, wherein the one ormore physiological responses include intended physiological activity andintolerable physiological activity, and wherein the method furthercomprises generating an output on the external device that prioritizesthe one or more electrode configurations that induce intendedphysiological activity based on a second capture threshold for theintended physiological activity.

In Example 20, the method according to Example 19, and furthercomprising programming the IMD with the external device to delivertherapy to at least one of the one or more electrode configurations thatinduce intended physiological activity at a lowest second capturethreshold.

While multiple embodiments are disclosed, still other embodiments of thepresent invention will become apparent to those skilled in the art fromthe following detailed description, which shows and describesillustrative embodiments of the invention. Accordingly, the drawings anddetailed description are to be regarded as illustrative in nature andnot restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows an embodiment of a neurostimulation system and portions ofan environment in which the neurostimulation system is used.

FIG. 2 shows another embodiment of a neurostimulation system andportions of an environment in which the neurostimulation system is used.

FIG. 3 is a block diagram illustrating an embodiment of portions of theneurostimulation system shown in FIG. 1.

FIG. 4 is a block diagram illustrating an embodiment of portions of theneurostimulation system shown in FIG. 2.

FIG. 5 is a flow diagram illustrating an embodiment of a process forselecting electrode configurations during implantation and positioningof a neural stimulation lead in the neurostimulation system shown inFIGS. 1 and 3.

FIG. 6 is a flow diagram illustrating an embodiment of a process forselecting electrode configurations after implantation of an implantablemedical device in the neurostimulation system shown in FIGS. 2 and 4.

While the invention is amenable to various modifications and alternativeforms, specific embodiments have been shown by way of example in thedrawings and are described in detail below. The intention, however, isnot to limit the invention to the particular embodiments described. Onthe contrary, the invention is intended to cover all modifications,equivalents, and alternatives falling within the scope of the inventionas defined by the appended claims.

DETAILED DESCRIPTION

FIG. 1 is an illustration of an embodiment of a neural stimulationsystem 10 and portions of an environment in which the system 10 is used.The system 10 includes an activity sensor 12 for sensing physiologicalactivity, a transvenous lead 14 for delivering vagal nerve stimulation,and an external system 16 coupled to the activity sensor 12 via a cable18 and coupled to the lead 14 via a cable 20. The external system 16,which in some embodiments is a programmer, allows for optimization ofthe vagal nerve stimulation using the sensed physiological activity.Examples of physiological activity that activity sensor 12 may beconfigured to sense include motor fiber activity, such as laryngealactivity and muscle activity, cough, change in blood pressure, change inheart rate, and/or evoked nerve response.

The lead 14 is a transvenous lead having a proximal end 22, a distal end24, and an elongate body 26 coupled between the proximal end 22 anddistal end 24. The proximal end 22 includes a connector 28. In theillustrated embodiment, the distal end 24 includes stimulationelectrodes 30 a, 30 b, 30 c, and 30 d. As illustrated in FIG. 1, a body32 includes a neck 34, a right internal jugular vein 36, a left internaljugular vein 38, a right subclavian vein 40, and a left subclavian vein41. The lead 14 is inserted using techniques similar to those employedin implanting cardiac pacing leads. During the insertion, the distal end24 enters the left subclavian vein 41 through an incision, advances inthe left subclavian vein 41 and then the right subclavian vein 40 towardthe right internal jugular vein 36, enters the right internal jugularvein 36, advances in the right internal jugular vein 36 until theelectrodes 30 a-30 d reach one or more vagal nerve stimulation sites.After the distal end 24 is in the right internal jugular vein 36, thestimulation electrodes 30 a-30 d are positioned, and repositioned whennecessary, using the lead 14 and/or a lead insertion tool such as astylet, a guide wire, or a guide catheter.

The electrodes 30 a-30 d allow neural stimulation to be delivered to avagus nerve 42, which is adjacent to the right internal jugular vein 36in the cervical region. In some embodiments, the activity sensor 12 isplaced on the neck over the larynx to sense a signal indicative oflaryngeal activity. In some embodiments, the activity sensor 12 issubstantially similar to the laryngeal activity sensor described in U.S.Patent App. Pub. No. 2008/0058874, which is hereby incorporated byreference in its entirety. The laryngeal activity is used as a measureof response of the vagus nerve 42 to the neural stimulation delivered tothe vagus nerve 42. In various embodiments, the laryngeal activity ismonitored for placement of stimulation electrodes such as the electrodes30 a-30 d, optimization of stimulation parameter such as thosecontrolling stimulation intensity (e.g., stimulation amplitude,frequency, duration, and duty cycle), and detection or monitoring ofvarious events that affect the response of the vagal nerve 42 to theneural stimulation.

While the electrodes 30 a-30 d are arranged to provide stimulation tothe vagus nerve 42, the lead 14 and electrodes 30 a-30 d may bepositioned to provide stimulation to other portions of the autonomicnervous system. For example, the lead 14 may alternatively be positionedto provide stimulation to baroreceptors or the spinal cord.

As illustrated in FIG. 1, the proximal end 22 remains outside of thebody 32, such as during an operation of implantation of the lead 14 andan implantable medical device such as one discussed below with referenceto FIG. 2. This allows the electrodes 30 a-30 d to be placed as desiredbefore connecting the proximal end 22 to the implantable medical device.The proximal end 22 includes a connector 28 coupled to a connector 44 ofthe cable 20 to allow delivery of the neural stimulation from theexternal system 16. The external system 16 allows a user such as aphysician or other caregiver to control the delivery of neuralstimulation via the lead 14 and monitor the signal indicative of larynxsensed by the activity sensor 12.

The configuration of the system 10 shown in FIG. 1 is an examplepresented for illustrative purposes. The present subject mattergenerally includes monitoring and optimization of nerve stimulationdelivered using any electrode configuration using any signal thatindicates physiological activity resulting from the vagal nervestimulation. For example, the lead 14 may include one or morestimulation electrodes, and an electrode pair for delivering the neuralstimulation may include two electrodes on the lead 14 or an electrode onthe lead 14 and a reference electrode not necessarily adjacent to thevagus nerve. In addition, while four electrodes 30 a-30 d are shown, thelead may include more or fewer electrodes 30 on the lead 14. In someembodiments, the reference electrode is a skin patch electrode for acuteuse. In some embodiments, in addition to, or instead of, the stimulationelectrodes 30 a-30 d on the lead 14, one or more nerve cuff electrodeseach surrounding vagus nerve 42 are used. Other possible electrodeconfigurations include a wrap electrode and/or spiral, straight, orbiased multipolar electrode configurations. In some embodiments, theelectrodes 30 a-30 d are placed in the left interval jugular vein 38. Inthese embodiments, during the insertion, the distal end 24 enters theleft subclavian vein 41 or right subclavian vein 40 through an incision,enters the left internal jugular vein 38 from right subclavian vein 40,advances in the left internal jugular vein 38 until the electrodes 30a-30 d reach one or more vagal nerve stimulation sites. Otherimplantation methods are also possible, such as implanting the lead inthe carotid sheath in the cervical region or other extravascularlocations near the neural target.

Further, while a single lead 14 is shown in FIG. 1, the system 10 can beconfigured to included a plurality of leads disposed in differentlocations in the patient. For example, the plurality of leads can bepositioned such that each lead is adapted to provide different types ofphysiological responses. In such a configuration, the automaticelectrode configuration described herein may be performed on each of theleads individually to optimize the neural response. In some exemplaryimplementations, the system 10 is configured to provide bilateral vagusnerve stimulation, multi-lead stimulation of the left and/or right vagusnerve, multi-lead spinal cord stimulation, stimulation of baroreceptors,or combinations thereof.

FIG. 2 is an illustration of an embodiment of a neural stimulationsystem 50 and portions of the environment in which the system 50 isused. The system 50 differs from the system 10 primarily in that theneural stimulation is delivered from an implantable medical device 52implanted in body 101. FIGS. 1 and 2 illustrate different stages ofimplantation and use of an implantable neural stimulation system. Inparticular, FIG. 1 illustrates a system setup in the middle of animplantation procedure during which the lead 14 is inserted with theelectrodes 30 a-30 d placed to achieve desirable performance of vagalnerve stimulation. FIG. 2 illustrates the system set-up after theimplantable neural stimulation system is fully implanted, such as duringthe end stage of the implantation procedure when the implantable neuralstimulation system is programmed for chronic use or during a follow-upexamination during which the implantable neural stimulation system isadjusted if necessary.

An activity sensor 54 represents an embodiment of the activity sensor 12(FIG. 1) that is capable of communicating with the external system 16via a wireless link. In some embodiments, the activity sensor 54 andexternal system 16 are wirelessly coupled through telemetry, representedas a communication link 56, such as a radio-frequency electromagnetictelemetry link.

The implantable medical device 52 delivers the neural stimulationthrough any combination of the electrodes 30 a-30 d. After theelectrodes 30 a-30 d are placed, the proximal end 22 of the lead 14 isconnected to the implantable medical device 52 via the connector 28.During operation, the lead 14 delivers electrical signals between theIMD 52 and the electrodes 30 a-30 d. The electrodes 30 a-30 d may beseparately controlled by the IMD 52, such that energy having differentmagnitude, phase, and/or timing characteristics may be delivered to orfrom each of the electrodes 30 a-30 d. In some embodiments, the housingof the implantable medical device 52 functions as a reference electrode,and the neural stimulation can be delivered using any electrodesselected from the electrodes 30 a-30 d and the housing of theimplantable medical device 52. In some embodiments, neural activity inthe vagus nerve 42 is sensed using any single or combined electrodesselected from the electrodes 30 a-30 d and the housing of theimplantable medical device 52. In some embodiments, in addition to theneural stimulation circuit, the implantable medical device 52 includesother monitoring or therapeutic circuits or devices such as one or moreof cardiac pacemaker, cardioverter/defibrillator, drug delivery device,and biological therapy device. The system 50 may alternatively beconfigured to include a plurality of leads 14, as discussed above.

Stimulating the sympathetic and parasympathetic nervous systems can haveeffects on physiological parameters associated with the heart, such asheart rate and blood pressure. In addition, stimulating the sympatheticnervous system dilates the pupil, reduces saliva and mucus production,relaxes the bronchial muscle, reduces the successive waves ofinvoluntary contraction (peristalsis) of the stomach and the motility ofthe stomach, increases the conversion of glycogen to glucose by theliver, decreases urine secretion by the kidneys, and relaxes the walland closes the sphincter of the bladder. Stimulating the parasympatheticnervous system (inhibiting the sympathetic nervous system) constrictsthe pupil, increases saliva and mucus production, contracts thebronchial muscle, increases secretions and motility in the stomach andlarge intestine, and increases digestion in the small intestine,increases urine secretion, and contracts the wall and relaxes thesphincter of the bladder. The functions associated with the sympatheticand parasympathetic nervous systems are many and can be complexlyintegrated with each other.

The vagus nerve 42 has afferent properties, such that the neuralstimulation is transmitted to the central nervous system (CNS). Vagalstimulation simultaneously increases parasympathetic and decreasessympathetic activity, and is believed to prevent further remodeling orpredisposition to fatal arrhythmias in post-MI patients, to help restoreautonomic balance and increase heart rate variability (HRV), to increaseparasympathetic and reduce sympathetic tone in hypertrophic cardiacmyopathy (HCM), neurogenic hypertension, and arrhythmia protection, toreduce anginal symptoms, to increase coronary blood flow (CBF), and toprevent development or worsening of congestive heart failure (CHF)following MI. The electrodes 30 a-30 d may be configured and arranged tostimulate the vagus nerve 42 to provide any of the physiologicalresponses described. While the electrodes 30 a-30 d are shown arrangedproximate the right vagus nerve 42 in FIGS. 1 and 2, the electrodes 30a-30 d can be configured and arranged to stimulate the left vagus nerveto treat other physiological and psychological conditions, such asepilepsy and depression.

The external system 16 provides for control of and communication withthe implantable medical device 52 by the user. The external system 16and the implantable medical device 52 are communicatively coupled via atelemetry link 58. In some embodiments, the external system 16 includesa programmer. The external system 16 can be used to adjust theprogrammed therapy provided by the IMD 52, and the IMD 52 can reportdevice data (e.g. battery information and lead resistance) and therapydata (e.g., sense and stimulation data) to the programmer using radiotelemetry, for example.

In other embodiments, the external system 16 is a patient managementsystem including an external device communicating with the implantablemedical device 52 via the telemetry link 58, a remote device in a remotelocation, and a telecommunication network linking the external deviceand the remote device. The patient management system allows access tothe implantable medical device 52 from the remote location, for purposessuch as monitoring patient status and adjusting therapies. In someembodiments, the telemetry link 58 is an inductive telemetry link. Inalternative embodiments, the telemetry link 58 is a far-fieldradio-frequency telemetry link.

FIG. 3 is a block diagram illustrating an embodiment of portions thesystem 10 (FIG. 1), including the activity sensor 12 and the externalsystem 16. In some embodiments, the activity sensor 12 includes anaccelerometer 70 to sense an acceleration signal being the signalindicative of physiological activity. The accelerometer 70 hascharacteristics suitable for sensing the magnitude and frequency ofvibrations of the larynx that indicate activity in the vagus nerve whenvagal nerve stimulation is delivered. In some embodiments, theaccelerometer 70 represents a plurality of accelerometers allowing forselection of an acceleration signal as the signal indicative ofphysiological activity based on the signal quality.

The external system 16 includes a neural stimulation analyzer 74, aneural stimulation circuit 76, an external controller 78, and a userinterface 80. The neural stimulation circuit 76 delivers the neuralstimulation to stimulation electrodes such as electrodes 30 a-30 d. Theexternal controller 78 controls overall operation of the external system16, including the delivery of the neural stimulation from the neuralstimulation circuit 76. In some embodiments, the external controller 78controls the neural stimulation circuit 76 to deliver neural stimulationto a plurality of electrode configurations, each electrode configurationincluding one or more of the electrodes 30 a-30 d. The user interface 80allows the user to control the neural stimulation and monitor theresponse of the vagus nerve to the neural stimulation. In someembodiments, the user interface 80 includes a display that provides avisual output relating to the response of the vagus nerve to the neuralstimulation.

The neural stimulation analyzer 74 includes a physiological activityinput 82, a neural stimulation input 84, and a processing circuit 86.The physiological activity input 82 receives a signal indicative ofphysiological activity from the activity sensor 12 via the cable 18. Inan alternative embodiment, the system 10 does not include an activitysensor 12, and clinician observations relating to physiological activityare provided to the physiological activity input 82 manually by aclinician. The neural stimulation input 84 receives a signal indicativeof the delivery of the neural stimulation to the vagus nerve. Theprocessing circuit 86 processes the signal indicative of physiologicalactivity for analyzing the operation and performance of system 10 usingthat signal. In addition, the processing circuit 86 associates theelectrode configurations that induce physiological activity with athreshold energy level at which the physiological activity is induced.

FIG. 4 is a block diagram illustrating an embodiment of portion of thesystem 50, including the activity sensor 54 coupled to the externalsystem 16 via the communication link 56, the implantable medical device52 coupled to the external system 16 via the communication link 58. Insome embodiments, the system 50 includes one or more additionalphysiological activity sensors 90 coupled to the external system 16 viaa communication link 91. The activity sensor 54 includes anaccelerometer 92 and a sensor telemetry circuit 93. In the illustratedembodiment, the communication link 56 is a telemetry link. The sensortelemetry circuit 93 transmits the sensed signal indicative ofphysiological activity (e.g., motor fiber activity) to the externalsystem 16 via the telemetry link 56.

The one or more physiological activity sensors 90 include sensortelemetry circuitry 94 that transmits signals indicative ofphysiological activity to the external system 16 via the telemetry link56. According to some embodiments, the physiological activity sensors 90include sensor assemblies to sense automatic nervous system (ANS)activity. The sensor can be used to provide feedback in a closed-loop.Examples of physiological activity capable of being detected by the oneor more physiological activity sensors 90 include coughing,voice-related physiological activity, such as voice alterations orlaryngismus, respiratory-related physiological activity, such as dyspneaand apnea, cardiac-related physiological activity, such as heart ratemodulation, bradycardia, tachyarrhythmias, and reduced cardiac output,and patient discomfort, such as nausea, inflammation of throat, abnormalsensations, and upset stomach. The one or more physiological activitysensors 90 can include various types of sensors and circuitry to detectphysiological activity. For example, an impedance sensor, anaccelerometer and/or acoustic sensor can be used to detect coughing. Anacoustic sensor can also be used to detect voice-related physiologicalactivity. Respiratory sensors, such as minute ventilation andtransthoracic impedance, can be used to detect respiratory-relatedphysiological activity. Cardiac-related physiological activity can bedetected using heart rate sensors, arrhythmia detectors, blood pressuresensors, and blood flow sensors. Patient and/or physician inputs relatedto patient discomfort may also be provided to the external device 16.Example embodiments of sensors suitable for the physiological activitysensors 90 are described in, for example, U.S. Pat. No. 7,561,923, U.S.Patent App. Pub. No. 2008/0086181, and U.S. Patent App. Pub. No.2008/0051839, each of which is incorporated by reference in itsentirety.

The external system 16 includes a neural stimulation analyzer 95, anexternal telemetry circuit 96, an external controller 98, and a userinterface 100. The external telemetry circuit 96 receives the signalindicative of physiological activity from the activity sensor 54 via thecommunication link 56 and, in some embodiments, signals indicative ofphysiological activity from the one or more physiological activitysensors 90 via the communication link 91. The external telemetry circuit96 also communicates with the implantable medical device 52 via thetelemetry link 58 to control the neural stimulation delivered from bythe implantable medical device 52. The external controller 98 controlsoverall operation of the external system 16, including the transmissionof commands for controlling the neural stimulation delivered from theimplantable medical device 52.

In this embodiment, the neural stimulation analyzer 95 includes aphysiological activity input 102, a neural stimulation input 104, and aprocessing circuit 106. The physiological activity input 102 receivesinputs indicative of physiological activity from the activity sensor 12via the communication link 56. In some embodiments, the physiologicalactivity input 102 also receives inputs from the one or morephysiological activity sensors 90 indicative of physiological activitygenerated during neural stimulation. In an alternative embodiment, thesystem 50 does not include an activity sensors 52 and/or 90, andclinician observations relating to physiological activity are providedto the physiological activity input 102 manually by a clinician. Theneural stimulation input 104 receives a signal indicative of thedelivery of the neural stimulation to the vagus nerve. The processingcircuit 106 processes the signals indicative of physiological activityfor analyzing the operation and performance of system 50. In addition,the processing circuit 106 associates the electrode configurations thatinduce physiological activity with threshold energy levels at which thephysiological activity are induced.

The implantable medical device 52 includes a neural stimulation circuit110, an implant controller 112, and an implant telemetry circuit 114.The neural stimulation circuit 110 delivers the neural stimulationthrough stimulation electrodes such as electrodes 30 a-30 d. The implantcontroller 112 controls the delivery of the neural stimulation and isresponsive to the commands transmitted from the external system 16. Theimplant telemetry circuit 114 receives the commands from the externalsystem 16 via the telemetry link 58 and when needed, transmits signalsto the external system 16 via the telemetry link 58.

The systems shown in FIGS. 1-4 are configured to facilitate selection ofone or more electrode configurations induce intended physiologicalactivity at low energies when neural stimulation signals are applied.The one or more electrode configurations include combinations of one ormore of the electrodes 30 a-30 d to which the neural stimulation signalsare applied. The external system 16 is employed to receive informationrelated to physiological activity that occurs in response to the neuralstimulation signals applied to each electrode configuration and providean output that assists a clinician in determining an optimal orpreferred electrode configuration(s). The selected one or more electrodeconfigurations may be a function of the capture threshold of thephysiological activity. As discussed above, FIGS. 1 and 3 illustratesystem configurations for selecting suitable electrode configurationsduring implantation of the lead 14 to get optimal positioning, and FIGS.2 and 4 illustrate system configurations for selecting suitableelectrode configurations after the IMD 52 has been implanted for aperiod of time (e.g., at a follow-up visit after implantation).

FIG. 5 is a flow diagram illustrating an embodiment of a process forselecting electrode configurations during implantation and positioningof the lead 14 in the neurostimulation system shown in FIGS. 1 and 3.Initially, the clinician positions the lead 14 and electrodes 30 a-30 dproximate the nerve 42. In some embodiments, the lead 14 is connected tothe external device 16 via a cable 20, as shown in FIG. 1. In analternative embodiment, the lead 14 is connected to the IMD 52 andcontrolled via a cable or telemetrically prior to implantation of theIMD 52.

In step 120, the external device 16 controls the neural stimulationcircuit 76 to deliver first neural stimulation pulses to a plurality ofconfigurations of the electrodes 30 a-30 d. The amplitude of the firststimulation pulses is selected to induce physiological activity in thepatient. In some embodiments, the external device 16 systematicallycycles through delivery of stimulation pulses to multiple electrodeconfigurations. In some embodiments, the electrode configurations arebipolar configurations. In other embodiments, the electrodeconfigurations are unipolar configurations or include more than twoelectrodes. The electrode configurations may include some or all of thepossible combinations of the electrodes 30 a-30 d for the number ofpoles selected. That is, a clinician may be able to omit certainelectrode configurations as being known to not generate a response(e.g., the electrodes are too far apart to provide a response). Forexample, if the lead 14 includes four electrodes 30-30 d as shown inFIG. 1, and bipolar stimulation is being tested, the external device 16delivers stimulation pulses to up to six electrode configurations: 30 aand 30 b, 30 a and 30 c, 30 a and 30 d, 30 b and 30 c, 30 b and 30 d,and 30 c and 30 d. As another example, if the lead 14 includes eightelectrodes, and bipolar stimulation is being tested, the external devicedelivers stimulation pulses to up to 28 electrode configurations.

In some embodiments, the external device 16 controls the neuralstimulation circuit 76 to deliver the first neural stimulation pulses atmore than one energy level for each of the electrode configurations. Inone exemplary implementation, the external device 16 controls the neuralstimulation circuit 76 to deliver the first stimulation pulses at 1 mAand 2 mA. The delivery of the first stimulation pulses at a plurality ofenergy levels helps identify the capture threshold for various electrodeconfigurations.

In step 122, the external device 16 receives information related tophysiological activity induced for each electrode configuration. Thephysiological activity may include, for example, motor fiber activity,such as laryngeal vibrations. In some embodiments, the informationrelated to physiological activity is received in the form of signalsfrom the activity sensor 12 provided to the physiological activity input82. In other embodiments, the information related to physiologicalactivity is provided as an input to the external system 16 on the userinterface 80 based on, for example, observations by the clinician.

In decision step 124, the external device 16 determines whetherphysiological activity is provided for a minimum number of poles (i.e.,electrode configurations). For example, the external device 16 maydisplay the results of step 122, and the clinician may decide whetherthe number of electrode configurations that induced physiologicalactivity is satisfactory. Alternatively, the minimum number of polesthat provide a laryngeal response may be programmed into the externaldevice 16, and the external device 16 may display a message or alertthat the minimum number of poles did not provide physiological activity.

If, in decision step 124, a minimum number of poles does not producephysiological activity, then, in step 126, the clinician repositions thelead 14 such that the electrodes 30 a-30 d are positioned differentlyrelative to the nerve 42. In some embodiments, the electrodes 30 a-30 dare moved cranially. In other embodiments, the electrodes 30 a-30 d aremoved caudally. The process then returns to step 120 to again test aplurality of electrode configurations.

If, in decision step 124, the minimum number of poles does producephysiological activity, then, in step 128, the external device 16generates an output that identifies the electrode configurations thatinduce physiological activity. For example, in some embodiments, theexternal device 16 displays the electrode configurations that inducephysiological activity. In embodiments in which the activity sensor 12detects the physiological activity, the external device 16 may alsodisplay the magnitude of physiological activity. In embodiments in whichthe external device 16 controls the neural stimulation circuit 76 todeliver the first neural stimulation pulses at more than one amplitude,the external device 16 may display the amplitude at which each electrodeconfiguration induces physiological activity (i.e., capture threshold).

In step 130, the external device 16 may facilitate storage of theelectrode configurations identified in step 128. For example, theexternal device 16 may store the electrode configurations, as well asany associated physiological activity magnitudes and capture thresholds,locally in a memory in the external device 16 or may transmit theinformation to a central server. The external device 16 may additionallyor alternatively provide the information related to the identifiedelectrode configurations for storage in the patient's record for futurereference. Steps 120-130 may be repeated for upright and supinepostures.

When the number of electrode configurations that induce physiologicalactivity is satisfactory, the lead 14 may be connected to the IMD 52,and the implantation procedure may be completed. After implantation,natural shifting of the lead 14 relative to the nerve 42 and tissueformation around the lead 14 and electrodes 30 a-30 d may have an effecton the electrode configurations that induce physiological activity. Thatis, the capture thresholds of the identified electrode configurationsmay change, or the electrode configurations that induce physiologicalactivity may change.

FIG. 6 is a flow diagram illustrating an embodiment of a process forselecting electrode configurations after implantation of an implantablemedical device in the neurostimulation system shown in FIGS. 2 and 4. Instep 140, the external device 16 controls the neural stimulation circuit110 in the IMD 52 to deliver first neural stimulation pulses to aplurality of configurations of the electrodes 30 a-30 d, similar to theprocess described above with respect to FIG. 5. In some embodiments, theexternal device 16 controls the neural stimulation circuit 110 todeliver the first neural stimulation pulses at more than one energylevel for each of the electrode configurations.

In step 142, the external device 16 receives information related tophysiological activity induced for each electrode configuration. Thephysiological activity may include, for example, motor fiber activity,such as laryngeal vibrations. In some embodiments, the informationrelated to physiological activity is received in the form of signalsfrom the activity sensor 54 provided to the physiological activity input102. In this embodiment, the physiological activity input 102 isconfigured to receive signals related to physiological activity inducedby neural stimulation signals. In other embodiments, the informationrelated to physiological activity is provided as an input to theexternal system 16 on the user interface 100 based on, for example,observations by the clinician.

In some embodiments, the external device 16 may then compare theelectrode configurations that induce physiological activitypost-implantation with the electrode configurations that inducephysiological activity pre-implantation. In addition, the externaldevice 16 may compare the pre- and post-implantation capture thresholdsfor each of the electrode configurations. This information can help theclinician determine, for example, whether the lead 14 has shifted sinceimplantation and whether electrode configurations different than thoseidentified during implantation would be more suitable for long termtherapy delivery.

In step 144, the external device 16 prioritizes the plurality ofelectrode configurations based on the capture threshold for each of theelectrode configurations. For example, the external device 16 maydisplay the electrode configurations in groups based on the lowestcapture threshold at which physiological activity is induced. Forexample, the external device 16 may display the electrode configurationsthat induce physiological activity at 1 mA in one group and theelectrode configurations that induce physiological activity at 2 mA inanother group.

In step 146, the external device 16 controls the neural stimulationcircuit 110 to deliver second neural stimulation pulses to one or moreelectrode configurations with a lowest capture threshold forphysiological activity. In an alternative embodiment, the externaldevice 16 controls the neural stimulation circuit 110 to deliver secondneural stimulation pulses to all electrode configurations that inducedphysiological activity. In some embodiments, the neural stimulationcircuit 110 is controlled to deliver the second neural stimulationpulses at more than one amplitude. The second neural stimulation pulses,which in some embodiments has an amplitude greater than the first neuralstimulation pulses, are configured to induce additional physiologicalactivity. For example, the second neural stimulation pulses may induceintended physiological activity such as heart rate modulation,atrioventricular (AV) conduction, and/or changes to the QRS complex andT wave electrocardiogram characteristics. The second neural stimulationpulses may also induce intolerable or undesirable physiologicalactivity, such as those discussed above.

In step 148, the external device 16 receives information related to thephysiological activity induced by the second neural stimulation signalsfor each electrode configuration tested. In some embodiments, theinformation related to the induced physiological activity is received inthe form of signals from the one or more physiological activity sensors90 provided to the physiological activity input 102. In otherembodiments, the information related to induced physiological activityis provided as an input to the external system 16 on the user interface100 based on, for example, observations by the clinician or statementsby the patient.

In step 150, the external device 16 prioritizes the plurality ofelectrode configurations based on which electrode configurations induceintended and intolerable physiological activity, and based on thecapture threshold at which intended physiological activity occur foreach of the electrode configurations. For example, the external device16 may display the one or more electrode configurations that inducephysiological activity in groups based on the lowest capture thresholdat which one or more intended physiological responses are induced. Theexternal device 16 may also exclude any of the electrode configurationsthat induce intolerable physiological activity. The external device 16may then display one or more recommended electrode configurations, alongwith a physiological activity profile for each of the electrodeconfigurations. Steps 140-150 may be repeated for upright and supinepostures.

In step 152, the clinician uses the external device 16 to program theIMD 52 to deliver therapy to at least one of the one or more electrodeconfigurations that induce intended physiological activity at the lowestcapture threshold. For example, if multiple electrode configurationsprovide similar intended physiological activity at the lowest capturethreshold, the external device 16 programs the IMD to cycle through theelectrode configurations periodically.

In some embodiments, the electrodes 30 a-30 d that are not employed fordelivery of neural stimulation signals may be defaulted into a pool foruse in other functions less impacted by the proximity of the electrode30 a-30 d to the therapeutic neural fibers. For example, the electrodes30 a-30 d that are not used for delivery of neural stimulation pulsesmay be employed to provide a wireless ECG vector to the IMD 52.

Various modifications and additions can be made to the exemplaryembodiments discussed without departing from the scope of the presentinvention. For example, while the embodiments described above refer toparticular features, the scope of this invention also includesembodiments having different combinations of features and embodimentsthat do not include all of the described features. Accordingly, thescope of the present invention is intended to embrace all suchalternatives, modifications, and variations as fall within the scope ofthe claims, together with all equivalents thereof.

We claim:
 1. A neurostimulation system comprising: an implantable neuralstimulation device having a plurality of electrodes and a neuralstimulation circuit, the plurality of electrodes configured forpositioning proximate a portion of the autonomic nervous system, theneural stimulation circuit configured to deliver neural stimulationpulses through the plurality of electrodes; a user interface, the userinterfacing including a display; and a controller configured to: reducea number of potential electrode combinations of the plurality ofelectrodes from a plurality of potential electrode combinations to asubset of potential electrode combinations for further testing,including: control the neural stimulation circuit to deliver a firstplurality of neural stimulation pulses to a neural target through theplurality of potential electrode combinations; receive informationindicative of physiological activity that is induced in response to thedelivery of the first plurality of neural stimulation pulses; use theinformation indicative of physiological activity to determine for eachof the plurality of electrode combinations whether the first pluralityof neural stimulation pulses captures neural tissue to inducephysiological activity; and group electrode combinations using thereceived information into the subset of potential electrode combinationsthat are associated with capturing neural tissue; determine that thesubset has at least a minimum number of potential electrode combinationsfor further testing, and identify on the display the subset of potentialelectrode combinations associated with capturing neural tissue; andfurther test the subset of potential electrode combinations that has aleast the minimum number of potential electrode combinations to furtherreduce the number of potential electrode combinations for deliveringneurostimulation pulses to the neural target.
 2. The neurostimulationsystem of claim 1, further comprising one or more physiological activitysensors configured to sense a signal indicative of the physiologicalactivity and generate the information indicative of the physiologicalactivity.
 3. The neurostimulation system of claim 1, wherein thereceived information further comprises undesirable physiologicalactivity induced in response to delivery of the first plurality ofneural stimulation pulses.
 4. The neurostimulation system of claim 3,wherein the controller is configured to remove from the subset anyelectrode combination associated with inducing the undesirablephysiological activity.
 5. The neurostimulation system of claim 1,wherein the physiological activity is associated with motor fiberactivity.
 6. The neurostimulation system of claim 1, wherein thecontroller is configured to: control the neural stimulation circuit todeliver a second plurality of neural stimulation pulses to the neuraltarget to further test the subset of potential electrode combinations,and receive additional information related to physiological activitythat is induced in response to delivery of the second plurality ofneural stimulation pulses.
 7. The neurostimulation system of claim 6,wherein the second plurality of neural stimulation pulses are deliveredat a higher pulse amplitude than the first plurality of neuralstimulation pulses.
 8. The neurostimulation system of claim 6, whereinthe second plurality of neural stimulation pulses are delivered at aplurality of different amplitudes.
 9. The neurostimulation system ofclaim 6, wherein the controller is configured to prioritize theelectrode combinations of the subset based on the additionalinformation.
 10. The neurostimulation system of claim 6, wherein thecontroller is configured to control the neural stimulation circuit todeliver the first plurality of neural stimulation before the implantableneural stimulation device is fully implanted and to deliver the secondplurality of neural stimulation after the implantable neural stimulationdevice is fully implanted.
 11. The neurostimulation system of claim 1,wherein the controller is configured to prioritize the electrodecombinations of the subset that induce intended physiological activitybased on a second capture threshold and indicate the second subset onthe display.
 12. The neurostimulation system of claim 11, wherein thecontroller is configured to control the neural stimulation circuit todeliver therapy through at least one electrode combination of thesubset.
 13. The neurostimulation system of claim 1, wherein thecontroller is an external controller and is configured to communicatewith the implantable neural stimulation device.
 14. The neurostimulationsystem of claim 1, wherein the controller is part of the implantableneural stimulation device.
 15. A method of automatic assessment of aplurality of electrodes of an implantable neural stimulation device, themethod comprising: reducing a number of potential electrode combinationsof the plurality of electrodes from a plurality of potential electrodecombinations to a subset of potential electrode combinations for furthertesting, including; delivering a first plurality of neural stimulationpulses to a neural target through the plurality of electrodecombinations; receiving information, at a controller, that is indicativeof physiological activity that is induced in response to delivery of thefirst plurality of neural stimulation pulses; using the informationindicative of physiological activity to determine for each of theplurality of electrode combinations whether the first plurality ofneural stimulation pulses captures neural tissue to induce physiologicalactivity; and grouping electrode combinations using the receivedinformation, including identifying, with the controller, the subset ofpotential electrode combinations associated with capturing neuraltissue; and determining that the subset has a at least a minimum numberof potential electrode combinations for further testing, and displaying,on a display, identification of the subset of more than one of theplurality of electrode combinations associated with capturing neuraltissue; and further testing the subset of potential electrodecombinations that has at least the minimum number of potential electrodecombinations to further reduce the number of potential electrodecombinations for delivering neurostimulation pulses to the neuraltarget.
 16. The method of claim 15, wherein the received informationfurther comprises undesirable physiological activity induced in responseto the delivery of the first plurality of neural stimulation pulses, andwherein identifying the subset further comprises removing from thesubset any electrode combination associated with inducing theundesirable physiological activity.
 17. The method of claim 15, whereinfurther testing the subset of potential electrode combinations includes:delivering a second plurality of neural stimulation pulses to the neuraltarget through the subset of electrode combinations; and receivingadditional information, at the controller, related to physiologicalactivity that is induced in response to delivery of the second pluralityof neural stimulation pulses.
 18. The method of claim 17, wherein thesecond plurality of neural stimulation pulses is delivered at a higherpulse amplitude than the first plurality of neural stimulation pulses.19. The method of claim 17, wherein the second plurality of neuralstimulation pulses is delivered at a plurality of different amplitudes.20. The method of claim 17, further comprising: prioritizing theelectrode combinations of the subset based on the additionalinformation; and displaying, on the display, an indication of theprioritization of the electrode combinations.